FDA acts to bolster supply of critically needed cancer drugs

The U.S. Food and Drug Administration  announced a series of steps to increase the supply of critically needed cancer drugs and build on President Obama’s Executive Order to help prevent future drug shortages. 

“A drug shortage can be a frightening prospect for patients and President Obama made it clear that preventing these shortages from happening is a top priority of his administration,” said FDA Commissioner Margaret A. Hamburg, M.D. “Through the collaborative work of FDA, industry, and other stakeholders, patients and families waiting for these products or anxious about their availability should now be able to get the medication they need.” 

In response to the critical shortage of the cancer drug Doxil (doxorubicin hydrochloride liposome injection) and rapidly declining supplies of methotrexate, the FDA took proactive steps needed to increase available supply for patients in the U.S. For Doxil, there will be temporary importation of a replacement drug, Lipodox which is expected to end the shortage and fully meet patient needs in the coming weeks. For methotrexate, in addition to already announced actions, the Agency has approved a new manufacturer of preservative-free formulation of methotrexate, that is expected to further bolster supply and help avert a shortage of this lifesaving medicine.  FDA expedited review of the application to help address this potential shortage.

Under FDA’s exercise of enforcement discretion the chemotherapeutic drug Lipodox will be imported as an alternative to Doxil. Temporary importation of unapproved foreign drugs is considered in rare cases when there is a shortage of an approved drug that is critical to patients and the shortage cannot be resolved in a timely fashion with FDA-approved drugs.

The Administration also announced on October 31, 2011, its support for bipartisan legislation  that would require all prescription drug shortages to be reported to FDA and would give FDA new authority to enforce these requirements. While additional manufacturing capacity is necessary to fully address the drug shortage problem, additional early notification to FDA can have a significant, positive impact on addressing the incidence and duration of drug shortages.